The following data is part of a premarket notification filed by Theratest Laboratories, Inc. with the FDA for Theratest El-rfscr.
| Device ID | K962050 |
| 510k Number | K962050 |
| Device Name: | THERATEST EL-RFSCR |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | THERATEST LABORATORIES, INC. 2201 WEST CAMPBELL PARK DR. Chicago, IL 60612 -3501 |
| Contact | Marius Teodorescu, Md., Ph.d. |
| Correspondent | Marius Teodorescu, Md., Ph.d. THERATEST LABORATORIES, INC. 2201 WEST CAMPBELL PARK DR. Chicago, IL 60612 -3501 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-28 |
| Decision Date | 1996-12-16 |